Cyclophosphamide
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE. CYCLOPHOSPHAMIDE for injection, for intravenous useInitial U.S. Approval: 1959
Approved
Approval ID
8627c83f-c057-495d-9f78-8b67bda97b3e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 31, 2022
Manufacturers
FDA
Civica, Inc.
DUNS: 081373942
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
cyclophosphamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72572-087
Application NumberANDA040745
Product Classification
M
Marketing Category
C73584
G
Generic Name
cyclophosphamide
Product Specifications
Route of AdministrationINTRAVENOUS, ORAL
Effective DateJuly 31, 2022
FDA Product Classification
INGREDIENTS (1)
CYCLOPHOSPHAMIDEActive
Quantity: 500 mg in 25 mL
Code: 8N3DW7272P
Classification: ACTIM
cyclophosphamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72572-085
Application NumberANDA040745
Product Classification
M
Marketing Category
C73584
G
Generic Name
cyclophosphamide
Product Specifications
Route of AdministrationINTRAVENOUS, ORAL
Effective DateJuly 31, 2022
FDA Product Classification
INGREDIENTS (1)
CYCLOPHOSPHAMIDEActive
Quantity: 1 g in 50 mL
Code: 8N3DW7272P
Classification: ACTIM
cyclophosphamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72572-083
Application NumberANDA040745
Product Classification
M
Marketing Category
C73584
G
Generic Name
cyclophosphamide
Product Specifications
Route of AdministrationINTRAVENOUS, ORAL
Effective DateJuly 31, 2022
FDA Product Classification
INGREDIENTS (1)
CYCLOPHOSPHAMIDEActive
Quantity: 2 g in 100 mL
Code: 8N3DW7272P
Classification: ACTIM